Epogen, Aranesp Misuse Rampant: Study

According to the findings of a new study, Anemia drugs like Epogen and Aranesp, are being widely misused.

Nearly a quarter of all patients who took the drugs, meant to prevent anemia during chemotherapy in cancer patients, were not on them long enough to receive any benefit, and 14% were given the drugs without actually being on chemotherapy.

In these cases, patients may have been exposed to Epogen and Aranesp side effects without actually receiving their health benefits, and medical insurers had to foot the bill for the expensive drugs for no reason, researchers reported in the Journal of Clinical Oncology.

Researchers from Columbia University in New York analyzed 5,099 patients over 65 with breast, lung or colon cancer who were given one of a class of drugs known as erythropoiesis-stimulating agents (ESAs) between 1995 and 2005. They found that 24% took the ESA for one week or less, which is likely too short a time to garner health benefits from the drugs. About 7.6% took the drug for longer than 14 weeks, which is too long to be on the drugs. Prescriptions for uses other than those approved by the FDA made up 13.6% of all ESA patients.

The scientists concluded that there is widespread variability in the use and misuse of anemia drugs and called for new policies to discourage inappropriate use of cancer drugs.

ESAs, which include Aranesp, Epogen and Procrit have been linked to an increased risk of heart attack, heart failure, stroke, blood clots and death.

Aranesp (darbepoetin alfa), Epogen (Epoetin alfa) and Procrit (Epoetin alfa) are prescribed to patients with kidney disease, anemia, HIV and cancer to stimulate bones to increase the production of red blood cells. They are also prescribed to patients preparing to undergo major non-heart surgery to reduce the number of transfusions such patients must receive. Amgen manufactures all three drugs, though Procrit is sold and marketed by Johnson and Johnson.

In 2008, Aranesp sales were $3.1 billion, and Procrit accounted for $2.46 billion in sales. Researchers estimate that by 2002, the drugs were being prescribed to nearly half of all cancer patients.

As more studies suggested that the drugs carried serious, sometimes deadly side effects, sales dropped in recent years. In 2007, the FDA issued a public health advisory regarding the drugs, saying that the Anemia drugs could increase the risk of injury or death at high doses. The FDA required that the drugs add a “black box warning” alerting patients to the cardiovascular health risks. The black box warning is the strongest label warning the FDA can require of a medication.

The drugs are already restricted under an FDA-required risk evaluation and mitigation strategy (REMS). Doctors and hospitals that wish to prescribe the drugs will now have to undergo special training to identify high risk users and negative side effects.